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  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group
    Preclinical, Journal, PD(L)-1 Biomarker, IO biomarker:  Apatinib enhanced anti-PD-1 therapy for colon cancer in mice via promoting PD-L1 expression. (Pubmed Central) -  Jun 9, 2021   
    The combination treatment showed more significant inhibition on the growth of transplanted tumors in mice than single-drug treatment. Overall, our study here showed the enhancement of anti-PD-1 antitumor efficacy in a syngeneic mouse model (CT-26 cells in Balb/c) by the angiogenesis inhibitor apatinib via upregulating PD-L1 expression as well as angiogenesis inhibition, which may provide a rationale for the combination of apatinib and anti-PD-1 antibody for colorectal cancer treatment in the clinic.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    [VIRTUAL] Topics for discussion () -  Jun 5, 2021 - Abstract #ASCO2021ASCO_5888;    
    PYR suppresses the proliferation, migration, and invasion of breast cancers through down-regulation of the Akt/p65/FOXC1 pathway. Risk factors (e.g., tobacco/alcohol consumption, exposure to environmental pollutants) for the development of head and neck cancer Diagnosis, screening and prevention strategies in SCCHN; molecular biomarkers and key pathways in the development and progression of SCCHN Clinical factors (e.g., pre-existing comorbidities, performance status and pathologic features) to consider when designing a therapeutic plan for patients with SCCHN Role of the human papillomavirus (HPV) in the development of head and neck cancers; impact of HPV status on the use of immune checkpoint inhibitors in SCCHN Factors guiding the selection of therapy for patients with SCCHN; influence of prior treatment, time since completion of definitive treatment, age, symptomatology, extent of metastases and PD-L1 expression status in the choice of treatment regimen Clinical role of concurrent and/or induction chemotherapy with radiation therapy for patients presenting with locoregional SCCHN Published research data with and current clinical role of cetuximab for patients with localized, recurrent or metastatic SCCHN; role of EGFR targeted therapies in the era of immunotherapy Prevalence and clinical implications of EGFR mutations in progressive SCCHN; recent FDA approval of a new dosage regimen for cetuximab Spectrum, frequency and severity of toxicities observed with cetuximab in combination with platinum-based chemotherapy; strategies to mitigate the associated side-effects Clinical utility of microsatellite instability (MSI) testing and PD-L1 status determinations using the tumor proportion score (TPS) and/or the combined positive score (CPS) for patients with SCCHN; similarities and differences in the available PD-L1 assay platforms Key efficacy and safety results supporting the FDA approval of pembrolizumab as first-line therapy in the Phase III KEYNOTE-048 trial for recurrent or metastatic SCCHN Optimal management of disease that progresses on pembrolizumab when administered as first-line therapy either alone or in combination with chemotherapy for patients with PD-L1-positive SCCHN Research databases supporting the use of immune checkpoint inhibitors for patients SCCHN; identification of patients with SCCHN who are ineligible for immune checkpoint inhibitor therapy Mechanism of action of and emerging results with camrelizumab alone or in combination with chemotherapy for recurrent or metastatic head and neck cancers Results from the Phase III KESTREL and EAGLE trials of the anti-PD-L1 antibody durvalumab with or without tremelimumab versus standard of care treatment for patients with recurrent or metastatic SCCHN Biologic rationale for the investigation of bempegaldesleukin in combination with pembrolizumab in a Phase II/III trial for patients with head and neck cancer whose tumors express PD-L1 CPS or 1 or more Updated results from the Phase III JAVELIN Head and Neck 100 study of avelumab in addition to chemoradiotherapy (CRT) versus CRT alone for untreated locally advanced SCCHN; recommendations for study termination Recognition, incidence, monitoring and optimal management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy Mechanisms of resistance to EGFR inhibition and immune checkpoint inhibition in SCCHN Mechanism of action of tipifarnib and published data with this agent in the Phase II RUN-HN trial in the cohort of patients with HRAS-mutant recurrent and/or metastatic SCCHN after disease progression on platinum-based chemotherapy; recent FDA breakthrough therapy designation Role of entrectinib and Larotrectinib in patients with NTRK gene fusion-positive salivary gland carcinomas Mechanism of action and rationale for the ongoing investigation of xevinapant in the Phase III TrilynX study for previously untreated high-risk locally advanced SCCHN
  • ||||||||||  AiTan (rivoceranib) / HLB Bio Group
    Retrospective data, Journal:  Efficacy and safety of low-dose apatinib in ovarian cancer patients with platinum-resistance or platinum-refractoriness: A single-center retrospective study. (Pubmed Central) -  Jun 5, 2021   
    Risk factors (e.g., tobacco/alcohol consumption, exposure to environmental pollutants) for the development of head and neck cancer Diagnosis, screening and prevention strategies in SCCHN; molecular biomarkers and key pathways in the development and progression of SCCHN Clinical factors (e.g., pre-existing comorbidities, performance status and pathologic features) to consider when designing a therapeutic plan for patients with SCCHN Role of the human papillomavirus (HPV) in the development of head and neck cancers; impact of HPV status on the use of immune checkpoint inhibitors in SCCHN Factors guiding the selection of therapy for patients with SCCHN; influence of prior treatment, time since completion of definitive treatment, age, symptomatology, extent of metastases and PD-L1 expression status in the choice of treatment regimen Clinical role of concurrent and/or induction chemotherapy with radiation therapy for patients presenting with locoregional SCCHN Published research data with and current clinical role of cetuximab for patients with localized, recurrent or metastatic SCCHN; role of EGFR targeted therapies in the era of immunotherapy Prevalence and clinical implications of EGFR mutations in progressive SCCHN; recent FDA approval of a new dosage regimen for cetuximab Spectrum, frequency and severity of toxicities observed with cetuximab in combination with platinum-based chemotherapy; strategies to mitigate the associated side-effects Clinical utility of microsatellite instability (MSI) testing and PD-L1 status determinations using the tumor proportion score (TPS) and/or the combined positive score (CPS) for patients with SCCHN; similarities and differences in the available PD-L1 assay platforms Key efficacy and safety results supporting the FDA approval of pembrolizumab as first-line therapy in the Phase III KEYNOTE-048 trial for recurrent or metastatic SCCHN Optimal management of disease that progresses on pembrolizumab when administered as first-line therapy either alone or in combination with chemotherapy for patients with PD-L1-positive SCCHN Research databases supporting the use of immune checkpoint inhibitors for patients SCCHN; identification of patients with SCCHN who are ineligible for immune checkpoint inhibitor therapy Mechanism of action of and emerging results with camrelizumab alone or in combination with chemotherapy for recurrent or metastatic head and neck cancers Results from the Phase III KESTREL and EAGLE trials of the anti-PD-L1 antibody durvalumab with or without tremelimumab versus standard of care treatment for patients with recurrent or metastatic SCCHN Biologic rationale for the investigation of bempegaldesleukin in combination with pembrolizumab in a Phase II/III trial for patients with head and neck cancer whose tumors express PD-L1 CPS or 1 or more Updated results from the Phase III JAVELIN Head and Neck 100 study of avelumab in addition to chemoradiotherapy (CRT) versus CRT alone for untreated locally advanced SCCHN; recommendations for study termination Recognition, incidence, monitoring and optimal management of immune-related adverse events in patients receiving immune checkpoint inhibitor therapy Mechanisms of resistance to EGFR inhibition and immune checkpoint inhibition in SCCHN Mechanism of action of tipifarnib and published data with this agent in the Phase II RUN-HN trial in the cohort of patients with HRAS-mutant recurrent and/or metastatic SCCHN after disease progression on platinum-based chemotherapy; recent FDA breakthrough therapy designation Role of entrectinib and Larotrectinib in patients with NTRK gene fusion-positive salivary gland carcinomas Mechanism of action and rationale for the ongoing investigation of xevinapant in the Phase III TrilynX study for previously untreated high-risk locally advanced SCCHN Apatinib 250 mg/d is a feasible treatment in platinum-resistant or platinum-refractory epithelial ovarian cancer (EOC) patients.
  • ||||||||||  Irene (pyrotinib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
    Trial initiation date:  Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer (clinicaltrials.gov) -  Jun 4, 2021   
    P2,  N=60, Recruiting, 
    Lenvatinib plus camrelizumab as post-progression treatment is effective and safe for advanced hepatocellular carcinoma with PD. Initiation date: Jan 2021 --> Jun 2021
  • ||||||||||  AiRuiKa (camrelizumab) / HLB Bio Group
    Enrollment change:  Camrelizumab Combined With CRT for Treatment of Patients With Local Recurrence of Esophageal Cancer (clinicaltrials.gov) -  Jun 3, 2021   
    P2,  N=236, Not yet recruiting, 
    Not yet recruiting --> Active, not recruiting | Trial completion date: Apr 2021 --> Dec 2022 | Trial primary completion date: Jun 2020 --> Dec 2021 N=100 --> 236